BRISTOL, Tenn. — The Food and Drug Administration has approved a topical treatment for genital warts made by Graceway Pharmaceuticals, the drug maker said Monday.
The FDA approved Zyclara (imiquimod) cream in the 3.75% strength for patients ages 12 years and older. According to clinical trial data, the cream effectively cleared genital warts, and of patients who achieved complete clearance, only a small percentage had a recurrence 12 weeks after treatment.
“Zyclara cream, which represents a significant advancement in the topical treatment of genital warts, works by increasing the immune response,” Harbor-UCLA Medical Center professor of obstetrics and gynecology Anita Nelson stated. “In my professional experience, genital warts commonly recur after treatment. Zyclara cream showed promising results in preventing genital wart recurrence for 12 weeks in the majority of patients who cleared during the clinical study.”